Study Comparing Linvoseltamab and Daratumumab for High-Risk Smoldering Multiple Myeloma

Sponsor: Regeneron Pharmaceuticals

Sponsor score: 60

ClinicalTrials ID:NCT07393282

Provider View

This clinical trial is testing whether the experimental drug linvoseltamab is more effective than daratumumab in delaying the progression of high-risk smoldering multiple myeloma to active multiple myeloma.

Patient Parameters

Program Overview

The purpose of this study is to compare two treatments, linvoseltamab (an experimental drug) and daratumumab, in people with high-risk smoldering multiple myeloma (HR-SMM). Researchers want to see if linvoseltamab can better delay the development of active multiple myeloma compared to daratumumab. The study will also look at potential side effects, how the drug is processed in the body, and if the body develops antibodies against the drug, which could affect its effectiveness or cause side effects.

Eligibility Criteria

Inclusion Criteria

  • Have a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Diagnosed with smoldering multiple myeloma (SMM) according to specific medical criteria.
  • Classified as high-risk for developing active multiple myeloma based on certain risk models.

Exclusion Criteria

  • Have signs of active multiple myeloma as defined by specific medical criteria.
  • Diagnosed with other specific blood disorders like systemic light chain amyloidosis or Waldenström macroglobulinemia.
  • Have a history of certain neurological conditions or movement disorders.
  • Have had a seizure in the past 12 months.
  • Have previously received treatments for plasma cell disorders, including chemotherapy, radiotherapy, or certain antibodies.
  • Currently receiving treatments that could interfere with the study.

Locations

FACILITYZIPCITYSTATE
Dana Farber / Harvard Cancer Center02215BostonMassachusetts

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